NDC 58809-359

Vanatol S

Butalbital, Acetaminophen And Caffeine

Vanatol S is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Gm Pharmaceuticals. The primary component is Butalbital; Acetaminophen; Caffeine.

Product ID58809-359_7ba6415e-6c07-ed83-e053-2a91aa0a4add
NDC58809-359
Product TypeHuman Prescription Drug
Proprietary NameVanatol S
Generic NameButalbital, Acetaminophen And Caffeine
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2017-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA040387
Labeler NameGM Pharmaceuticals
Substance NameBUTALBITAL; ACETAMINOPHEN; CAFFEINE
Active Ingredient Strength50 mg/15mL; mg/15mL; mg/15mL
Pharm ClassesBarbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58809-359-30

12 BOTTLE in 1 CARTON (58809-359-30) > 30 mL in 1 BOTTLE
Marketing Start Date2017-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58809-359-30 [58809035930]

Vanatol S SYRUP
Marketing CategoryANDA
Application NumberANDA040387
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-07-01

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/15mL

OpenFDA Data

SPL SET ID:2e1c1554-61e9-4f46-ac18-e321e01adc0c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1648584
  • 756245
    • UPC Code
  • 0358809359301

    • Pharmacological Class

    • Barbiturates [CS]
    • Barbiturate [EPC]
    • Central Nervous System Stimulant [EPC]
    • Methylxanthine [EPC]
    • Xanthines [CS]
    • Central Nervous System Stimulation [PE]

    NDC Crossover Matching brand name "Vanatol S" or generic name "Butalbital, Acetaminophen And Caffeine"

    NDCBrand NameGeneric Name
    58809-359Vanatol SVanatol S
    0143-1787Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    0527-4094butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    0904-6538Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    10135-628Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    10702-253Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    11534-187BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeine
    13107-075Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    13925-535BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeine
    13925-536BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeine
    17856-1787Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    21695-257Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    21695-843Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    42195-955Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    42543-094Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    43063-369Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    46672-053butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    46672-633butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    50090-2105Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    50268-139Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    50436-4856butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    51407-200BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeine
    51407-556Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    51862-179butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    51862-540butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    51862-542butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine

    Trademark Results [Vanatol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VANATOL
    VANATOL
    86527496 5176909 Live/Registered
    GM Pharmaceuticals, Inc.
    2015-02-06
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